&lt;p&gt;Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 μg/Drospirenone 3 mg in a Real-World Setting: An Observational Study&lt;/p&gt;

Momoeda, Mikio; Akiyama, Sayako; Tanaka, Kota; Suzukamo, Yoshimi

doi:10.2147/ijwh.s238460

Cited by 7 publications

(25 citation statements)

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“…The results of this analysis are consistent with those of a previous real-world study of the cyclic regimen of EE/DRSP, which showed that 6–8 cycles of treatment had a positive impact on HRQL in Japanese women with dysmenorrhea ( n = 186), as assessed using the 36-Item Short-Form Health Survey [ 27 ]. Similar results have also been observed in recent studies (including prospective clinical trials) with other hormonal treatments; improvements in HRQL in patients with endometriosis-associated pain or dysmenorrhea have been demonstrated with pharmacotherapies such as combined oral contraceptives, gonadotropin-releasing hormone receptor antagonists, and subdermal implant and oral formulations of progestin [ 36 – 40 ].…”

Section: Discussionsupporting

confidence: 88%

“…Clinical studies in Japanese women have demonstrated that the cyclic regimen of EE/DRSP improved HRQL outcomes associated with dysmenorrhea [ 27 ], the cyclic and extended regimens reduced dysmenorrhea-related pain [ 25 , 28 ], and the extended regimen improved endometriosis-related pain [ 29 ]. However, the impact of the extended regimen of EE/DRSP on HRQL in patients with dysmenorrhea or endometriosis-associated pain in a real-world setting has not been determined.…”

Section: Introductionmentioning

confidence: 99%

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Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study

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Introduction Dysmenorrhea and endometriosis are common gynecologic disorders among women of reproductive age that significantly impact health-related quality of life (HRQL) as well as productivity. Although there are treatment options listed in Japanese guidelines, a gap remains in unmet medical needs for maximizing treatment outcome. The extended regimen of ethinylestradiol and drospirenone (EE/DRSP) (taken daily for up to 120 consecutive days) has been available in Japan for treating dysmenorrhea and/or endometriosis-associated pain since 2016. Yet, the effectiveness of its usage on HRQL has not been investigated elsewhere to date. Therefore, in this study, we aim to observe changes in HRQL of Japanese women treated with an extended regimen of EE/DRSP for dysmenorrhea and/or endometriosis-associated pain. Methods As part of a 2-year post-marketing surveillance study, women with dysmenorrhea or endometriosis-associated pelvic pain were prescribed extended EE/DRSP during routine clinical practice. Data were collected 1 month before and 3 and 6 months after initiating treatment. Primary outcomes were the Menstrual Distress Questionnaire (MDQ) (before, during, and after menstruation) in patients with dysmenorrhea, and the Endometriosis Impact Scale (EIS) and European Quality of Life 5-dimensions 5-level instrument (EQ-5D-5L) in patients with endometriosis. Results The study cohort included 315 patients (mean age 28.9 years) with dysmenorrhea and 262 patients (mean age 31.3 years) with endometriosis. Mean MDQ total scores before and during menstruation decreased significantly after 6 months with extended EE/DRSP; there was no improvement in after-menstruation MDQ score. Mean EIS domain scores improved significantly by 6 months, with improvement in most EIS individual item scores. Mean EQ-5D-5L scores increased slightly during 6 months of treatment. Conclusions Extended EE/DRSP treatment improved HRQL outcomes in Japanese women with dysmenorrhea or endometriosis-associated pelvic pain. Trial Registration Registered at ClinicalTrials.gov (NCT03126747) on June 2017. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02301-3.

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Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study

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“…Although numerous studies have investigated the impact of dysmenorrhea on HRQL, only one publication investigated the benefits of taking LEP in Japan [ 17 ]. A patient-reported outcome study of Japanese women with dysmenorrhea treated with ethinylestradiol/drospirenone (EE/DRSP) showed HRQL improvements, as measured by the 36-Item Short-Form Health Survey version 2.0 (SF-36v2.0) [ 17 ]. However, studies investigating the impact of cyclic or extended LEP regimens on HRQL or examining the relationship between HRQL and work productivity in Japanese women are lacking.…”

Section: Introductionmentioning

confidence: 99%

Menstrual Symptoms, Health-Related Quality of Life, and Work Productivity in Japanese Women with Dysmenorrhea Receiving Different Treatments: Prospective Observational Study

2022

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Introduction Dysmenorrhea is a physical and mental burden for women, negatively affecting health-related quality of life (HRQL) and work productivity. However, data on HRQL and work productivity of Japanese women are scarce. Methods In this prospective observational study, 397 Japanese women received low-dose estrogen/progestin (LEP) or non-LEP treatment (non-steroidal anti-inflammatory drugs or Chinese herbal medicines) for primary/secondary dysmenorrhea and completed survey questionnaires online regarding menstrual symptoms, HRQL, and work productivity. Regression analysis was performed to compare the groups and evaluate outcomes over time using the paired t test. Subgroup analysis was performed using stratification by patient background, and correlations between improvement in menstrual symptoms/HRQL and work productivity were investigated using Spearman’s rank correlation coefficient. Results Significant reductions in the modified Menstrual Distress Questionnaire (mMDQ) total score were shown in the LEP group ( n = 251) ( P < 0.01), but not the non-LEP group ( n = 146). Significant improvements in HRQL, measured by the 36-Item Short-Form Health Survey v2.0 (SF-36v2.0), were shown in the LEP group, but not the non-LEP group. Improvements were seen in mental component summary and 7/8 domains (role physical, bodily pain, general health, role emotional, mental health, vitality, and social functioning) in the LEP group, but not the non-LEP group. There were no differences in the physical component summary and role functioning in either group. Improvements in work productivity, measured by the modified Work Productivity and Activity Impairment Questionnaire (mWPAI), were greater in the LEP group vs. non-LEP group. Regression analysis showed differences in improvements between the groups in the mMDQ total score, SF-36v2.0, and mWPAI. A correlation between mMDQ or HRQL and work productivity was seen. Conclusion In Japanese women, dysmenorrhea is associated with reduced HRQL and work productivity. In real-world clinical practice, improvements in physical and mental menstrual symptoms, HRQL, and work productivity were observed with LEP treatment. Trial Registration NCT04607382 (ClinicalTrials.gov). Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02118-0.

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“…An improvement in total MDQ scores was observed in both the premenstrual and menstrual periods, meaning that the LNG-IUS may improve various symptoms before and during menstruation. The onset of primary dysmenorrhea usually occurs on the first day of menstruation; the severity is generally higher during the initial 24–48 h [ 34 ]. This may explain why the total MDQ score at baseline in our study tended to be higher during the menstrual period than the premenstrual period.…”

Section: Discussionmentioning

confidence: 99%

Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting

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Introduction The present study collected 1-year follow-up patient-reported outcome data from Japanese women with dysmenorrhea and/or heavy menstrual bleeding (HMB) who underwent insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg. We aimed to evaluate the quality of life (QOL) of Japanese women over the course of the investigational period. Methods This was a multicenter, non-interventional, prospective, single-cohort, post-marketing surveillance study (J-MIRAI). The primary outcome was the median change in the Menstrual Distress Questionnaire (MDQ) and Menorrhagia Multi-Attribute Scale (MMAS) scores from baseline to 3 and 12 months after LNG-IUS insertion, with decreasing and increasing scores, respectively, indicating improvement. The secondary outcomes were the statistical relationships between the MDQ and menstrual pain (measured by a visual analog scale, VAS), and between the MMAS and pictorial blood loss assessment chart (PBAC) scores by regression analysis. Results In total, 593 patients were evaluated; 376, 467, and 250 patients were diagnosed with dysmenorrhea, HMB, or both, respectively. The median MDQ score decreased significantly at 3 and 12 months after LNG-IUS insertion in both the premenstrual and menstrual periods (both p < 0.001 vs baseline), and the median MMAS score showed a similar improvement during the menstrual period. Changes in median MDQ and MMAS scores were observed regardless of patient background. Correlations between MDQ and menstrual pain (VAS) and between MMAS and PBAC scores were found (estimated regression coefficients 0.29 and − 0.15, respectively). Conclusion The LNG-IUS contributed to improvements in the QOL of patients with dysmenorrhea, HMB, and both, regardless of patient background characteristics. Trial Registration Registered at ClinicalTrials.gov (NCT02475356) on 18 June 2015. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02205-2.

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<p>Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 μg/Drospirenone 3 mg in a Real-World Setting: An Observational Study</p>

Cited by 7 publications

References 28 publications

Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study

Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study

Menstrual Symptoms, Health-Related Quality of Life, and Work Productivity in Japanese Women with Dysmenorrhea Receiving Different Treatments: Prospective Observational Study

Quality of Life of Japanese Dysmenorrhea/Heavy Menstrual Bleeding Patients Treated with Levonorgestrel Intrauterine Delivery System in a Real-World Setting

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